UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012752 |
|---|---|
| Receipt number | R000014867 |
| Scientific Title | A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2020/12/02 08:21:53 |
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Basic information
Public title
A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Acronym
NECTOR
Scientific Title
A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Scientific Title:Acronym
NECTOR
Region
| Japan |
Condition
Condition
Unresectable pancreatic neuroendocrine carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety in patients with unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival, time to treatment failure, response rate, disease control rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Everolimus 10mg once daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically confirmed pancreatic neuroendocrine carcinoma
2) No indication for surgical resection
3) 20 years of age or over
4) ECOG performance status 0-2
5) Refractory or intolerant to platinum-based regimen
6) Having evaluable lesion by CT
7) No previous chemotherapy within 3 weeks
8) Adequate organ function
9) Written informed consent
Key exclusion criteria
1) NET G1 or G2 by WHO 2010 criteria
2) Interstitial pneumonia or plumonary fibrosis
3) Metastasis to the central nervous system
4) Concomitant malignancy within 3 years
5) Active infection (exept for hepatitis B or C viral infection)
6) Active gastrointestinal ulcer
7) Severe or uncontrollable complications, such as cardiovascular impairment, infection, diabetes mellitus, and pulmonary disease
8) Severe mental disorder
9) Continuous administration of steroid or immunosuppressant
10) Prior treatment of mTOR inhibitor
11) Pregnant or lactating women and women of childbearing age who were not using effective contraception
12) Patients who was judged to be inappropriate for this study by each investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Ikeda |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL
+81-4-7133-1111
masikeda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okuyama |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL
+81-4-7133-1111
Homepage URL
hokuyama@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Cancer Fundation
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県がんセンター中央病院（愛知県），石川県立中央病院（石川県），大阪府立成人病センター（大阪府），岡山大学（岡山県），香川大学（香川県），神奈川県立がんセンター（神奈川県），金沢大学（石川県），がん研究会有明病院（東京都），関西医科大学（大阪府），北里大学東病院（神奈川県），九州大学（福岡県），京都府立医科大学（京都府），杏林大学（東京都），神戸大学（兵庫県），国立がん研究センター中央病院（東京都），国立がん研究センター東病院（千葉県），国立国際医療研究センター（東京都），大阪医療センター（大阪府），九州がんセンター（福岡県），四国がんセンター（愛媛県），埼玉県立がんセンター（埼玉県），札幌医科大学（北海道），静岡県立静岡がんセンター（静岡県），自治医科大学（栃木県），千葉大学（千葉県），手稲渓仁会病院（北海道），東海大学（神奈川県），東京慈恵会医科大学（東京都），東京慈恵会医科大学附属柏病院（千葉県），東京大学（東京都），富山大学（富山県），名古屋市立西部医療センター（愛知県），宮崎大学（宮崎県），横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014867
